Biotech/Pharma Docket

    By James DeGiulio --

Teva and Novartis Settle Patent Dispute over Zometa

Teva Pharmaceuticals Industries Ltd. and Novartis Corp. have reached an agreement to settle their patent suit over a generic version of Zometa, a drug used to prevent skeletal fractures.

Teva first sent Novartis two Paragraph IV notices on June 10, 2008, claiming that Novartis' U.S. Patent No. 4,939,130 was either invalid, unenforceable, or wouldn't be infringed by Teva's proposed generic.  Novartis claimed that Teva had inappropriately sent the Paragraph IV notices before filing its ANDA (see "Court Report," August 3, 2008).  Thus, Novartis asked the District Court to declare Teva's Paragraph IV notices invalid and require the company to file new notices before the clock on the 30-month stay can start.

The parties subsequently reached an agreement, with Judge Sue Robinson of the U.S. District Court for the District of Delaware signing off on the parties' stipulation of dismissal.  The stipulation dismisses without prejudice all claims, counterclaims, and defenses in the action.  Both Teva and Novartis will pay their own costs and attorneys' fees.  No other details were available.

View Novartis' complaint here.

Judge Robinson's dismissal order can be found here.

Teva, Sun Fail to Overturn Jury Verdict Finding Pfizer Protonix Patent Valid

Teva and Sun's allegations that Pfizer's Protonix patent was invalid as obvious and invalid for double patenting were rejected in a recent court decision, which upholds an earlier jury verdict affirming the validity of Pfizer's U.S. Patent No. 4,758,579, covering the heartburn drug.

Wyeth, the licensee of the '579 patent and now part of Pfizer, and Altana Pharma AG, now part of Nycomed, brought a patent infringement suit against Teva in May 2004 following Teva's ANDA filing.  In September 2007, Judge Jose L. Linares of the U.S. District Court for the District of New Jersey found that Teva had raised sufficient issues over the patent's validity, and denied a motion for preliminary injunction to stop Teva from launching generic versions of Protonix.  In April, a jury found the '579 patent valid, disagreeing with allegations by Teva and other generic firms that the patent was invalid based on obviousness and double-patenting (see "Biotech/Pharma Docket," May 10, 2010).

Judge Linares has now affirmed the April 23 jury verdict, finding that all issues regarding validity and infringement of the Protonix patent have been decided in Pfizer's favor.  Pfizer will now pursue its damage claims from the at-risk launch of generic versions of the drug by Teva and Sun.  Teva reiterated its belief the patent was invalid and unenforceable and planned to pursue all available legal remedies, including appeals.

Sandoz Loses Motion for Interlocutory Appeal in Effexor Patent Suit with Wyeth

Sandoz's bid for an interlocutory appeal has been denied following a grant of partial summary judgment for Wyeth in a patent infringement suit over the depression and anxiety drug Effexor.

Wyeth sued Sandoz in 2007, claiming that Sandoz's ANDA infringed three patents, U.S. Patent Nos. 6,419,958, 6,403,120, and 6,274,171 (see "Court Report," July 1, 2007).  Following a Markman hearing, Wyeth moved for summary judgment regarding Sandoz's direct infringement, active inducement of infringement, and contributory infringement of several claims in the three patents.  On March 12, Judge James Denver of the U.S. District Court for the Eastern District of North Carolina granted Wyeth's motion for summary judgment over all the infringement claims against Sandoz.  At the same time, he denied Sandoz's motion for summary judgment for noninfringement and invalidity, finding the defendant's arguments based on inappropriate claim construction.  Following this ruling, Sandoz asked Judge Denver to immediately certify his order granting summary judgment to Wyeth for an interlocutory appeal.

On July 14, Judge James ruled that Sandoz failed to meet the standard necessary for an interlocutory appeal.  Judge Denver had construed the term "extended release formulation" broadly to include a formulation that releases the active ingredient at a slower rate than the original formulation.  Judge Denver found no substantial ground for difference of opinion over the term such that an interlocutory appeal was warranted.  The judge also ruled that because the issues raised by Sandoz were not controlling questions of law, an interlocutory appeal would not materially advance the litigation.

Judge James' order can be found here.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law.  Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at degiulio@mbhb.com.